Taiwan's Glac Biotech Receives FDA GRAS Approval for Probiotic Strain CP-9, Expanding Infant Nutrition Portfolio
Key Insights
Glac Biotech (search)'s probiotic strain CP-9 (search) (Bifidobacterium lactis CCTCC M 2014588 (search)) has received FDA GRAS approval for use up to 10⁹ CFUs per serving across diverse food and beverage products.
The Taiwan-based company becomes the only probiotic raw material manufacturer in Taiwan to hold multiple FDA GRAS approvals, following MP108's recognition in 2023.
CP-9 (search) has been studied for gut health and immune regulation benefits and is expected to serve infant and family nutrition markets alongside established strains.
Taiwan-based Glac Biotech (search) announced that its core probiotic strain CP-9 (search) (Bifidobacterium lactis CCTCC M 2014588 (search)) has received Generally Recognized as Safe (GRAS) status from the U.S. Food and Drug Administration (search), marking a significant regulatory milestone for the company's expanding probiotic portfolio.
The approval makes Glac Biotech (search) the only probiotic raw material manufacturer in Taiwan to hold multiple FDA GRAS approvals, following the recognition of Lactobacillus rhamnosus MP108 (search) in 2023.
Broad Application Across Food Categories
According to the FDA filing, CP-9 (search) is authorized for use at levels up to 10⁹ colony-forming units (CFUs) per serving in an extensive range of food and beverage products. The approved applications include sports and energy drinks, fortified waters, bottled teas, cereals, dairy and non-dairy items, nutrition bars, candies, fruit juices, soy and plant-based protein products, and infant foods.
The newly approved CP-9 (search) was a finalist at the 2023 NutraIngredients Awards and has been studied for its role in gut health and immune regulation. With FDA GRAS status, CP-9 expands Glac Biotech (search)'s portfolio and is expected to serve the infant and family nutrition markets alongside established strains such as Bifidobacterium lactis BB-12 (search).
Building on Previous Regulatory Success
Glac Biotech (search)'s first GRAS-notified strain, MP108, was shortlisted for the NutraIngredients Awards in 2021 and approved by the FDA in 2023. It was the first probiotic strain in Asia to be approved for infant use. Supported by clinical and safety data, MP108 is permitted for use at up to 10⁹ CFUs per serving in sports and energy drinks, fortified waters, nutritional beverages, bottled teas, processed fruits and juices, cereals, cheeses, yogurts, milk-based desserts, soy-based products, nutrition bars, candies, and infant foods.
Advancing Postbiotic Innovation
Beyond probiotics, Glac Biotech (search) is advancing in postbiotics with its flagship product Totipro® (search), which is available in Europe, Southeast Asia, and North America. The company plans to submit Totipro® for FDA GRAS approval in the near future. Totipro® is the only raw material publicly declared to meet all four postbiotic categories defined by the International Probiotics Association (search) (IPA): intact cells (IC), cell fragments and cytoplasmic contents (FC), microbial metabolites (MM), and fermentation media containing microbial components (CX).
Company Leadership Perspective
"FDA GRAS approval represents an important standard of quality and safety. With CP-9 (search) now approved, MP108 already recognized, and Totipro® (search) submission soon, Glac Biotech (search) is advancing its probiotics and postbiotics research with consistency and international alignment. We will continue to base our work on scientific evidence, cooperating with partners worldwide to develop reliable health solutions," concluded Shin-Yu Tsai, Product and Marketing Department Manager of Glac Biotech.
Founded in 2008, Glac Biotech (search) is a subsidiary of Center Laboratories Inc. (search), Taiwan's largest liquid pharmaceutical manufacturer. The company focuses exclusively on probiotics (PRONULIFE® (search)) and postbiotics (Totipro® (search)), with over 30 researchers and 30 quality specialists overseeing strain development, patents, clinical validation, and international certification.